An interventional study of probiotic and Placebo in Familial Mediterranean Fever (FMF ), sponsored by Rambam Health Care Campus. Withdrawn. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2016-10-07.
Sponsored by Rambam Health Care Campus · Not applicable, Interventional, and Treatment
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Colchicine is the drug of choice to treat patients with Familial Mediterranean Fever (FMF ), some of the patients treated with colchicine may suffer from gastrointestinal (GIT) adverse effect such as diarrhea and abdominal pain especially in the higher dose.
5-10% of the patients with FMF that have been treated with colchicine may have partial or no response to this therapy.
Aim of our study: the aim of our study is :.1to evaluate the efficacy of probiotics in reducing the number of adverse effect in patients with FMF that are being treated with colchicine and suffering from GIT adverse effect.
.2 To evaluate the efficacy of probiotics in reducing the number of FMF attacks in children with FMF that has been treated with colchicine with only partial response.
Methods: the study will be done among children (5-17 years old) with FMF that are currently followed in the pediatric rheumatology clinic at Mayer children hospital Israel Haifa that are being treated with colchicine and suffering from either GIT adverse effect or partial response to colchicine.
The study is design to be double blind placebo control, in the first 3 month patients will be with no therapy and will be required to record all there FMF episodes and their GIT adverse effect, in the second period the patients will be randomly divided into two groups 1.patients that will received placebo (group 1) and the 2. Probiotics group - patients will received probiotics (Bio -25 including 11 types of bacteria L.acidophilus, B.bifidum , L.rhamnosus, L.lactis, L.casei, B.breve, B.thermophilus, B.longum, L.paracseis, L.plantarum, B.infantis), both for three month, during this period patient will be required to record their gastrointestinal symptoms and other symptoms that may be related to FMF.
61 studies on the registry are indexed under Familial Mediterranean Fever; 27 are open to participants now.
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Exclusion Criteria:
children (5-17 years old) with FMF that are currently followed in the pediatric rheumatology clinic at Mayer children hospital Israel Haifa that are being treated with colchicine and suffering from either gastrointestinal adverse effect or partial response to colchicine.in the first 3 month patients will be followed with no interventions and will be required to record all there FMF episodes and their GIT adverse effect, in the second period the patients will be randomly divided into two groups patients that will received placebo arm one and patients that will receive probiotics arm two.
Dietary Supplement: Placebo
children (5-17 years old) with FMF that are currently followed in the pediatric rheumatology clinic at Mayer children hospital Israel Haifa that are being treated with colchicine and suffering from either gastrointestinal adverse effect or partial response to colchicine.in the first 3 month patients will be followed with no interventions and will be required to record all there FMF episodes and their GIT adverse effect, in the second period the patients will be randomly divided into two groups patients that will received placebo arm one and patients that will receive probiotics arm two.
Dietary Supplement: probiotic
Probiotics group - patients will received probiotics Bio -25 including 11 types of bacteria total of 25 billion germs in each capsule, patients will received one capsule a day for 3 month.
Also known as: Bio 25
Placebo group - patients will received placebo patients will received one capsule a day for 3 month.
The number of gastrointestinal adverse effect related to colchicine therapy after adding probiotics to colchicine therapy.
The number of gastrointestinal adverse effect will be measured 3 months before starting the intervention and after 3 months patients will received either placebo or probiotics the measures will be : 1. Number of days with at least one episode of loose stool. 2. Number of days with abdominal pain not related to FMF attacks.
Time frame: 6 months after enrollment assumed to be at 12/2014
Number of FMF attacks after adding the probiotics to the colchicine therapy
The number of attacks will be measured 3 months before starting the intervention and after 3 months patients will received either placebo or probiotics . Attacks will defined as fever with one of the above : a. abdominal pain b.pleuritic chest pain c.arthritis d.erysipelas like .
Time frame: 6 months after enrollment assumed to be at 12/2014
No study locations are listed for this record.
The record gives a start of Dec 2013, a primary completion of Dec 2014 and a completion of Dec 2014. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Probiotic
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